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CHMP Endorses Merck's (MRK) Keytruda Expansion in Gastric Cancer
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Merck (MRK - Free Report) announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending label expansion to its blockbuster drug Keytruda as part of a combination regimen for a second indication in gastric cancer.
The CHMP has recommended approving Merck’s Keytruda, combined with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (“GEJ”) adenocarcinoma, whose tumors express PD-L1.
This recommendation is based on data from the phase III KEYNOTE-859 study, wherein patients treated with the Keytruda combination demonstrated a statistically significant improvement in overall survival compared to those patients who received chemotherapy only.
If approved, a combination therapy involving Keytruda will be available to patients with both HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma whose tumors express PD-L1.
In August, the European Commission (“EC”) approved the combination of Keytruda, trastuzumab and chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in patients whose tumors express PD-L1. Merck received accelerated approval from the FDA in 2021 for the Keytruda-trastuzumab-chemotherapy combination in a similar indication.
Merck’s shares have lost 6.3% year to date against the industry’s 8.5% growth.
Image Source: Zacks Investment Research
Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug approved for several types of cancer, accounting alone for around 40% of MRK’s pharmaceutical sales. Keytruda is presently authorized to treat seven indications in earlier-stage cancers in the United States. Merck’s Keytruda continuously grows and expands into new indications and markets globally.
Keytruda, the key revenue generator for Merck, is already approved for treating many cancers globally. In the first half of 2023, Merck recorded $12.1 billion in sales from Keytruda, up 20% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. Keytruda is consistently growing and expanding into new indications and markets globally.
Merck is evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1600 studies, including combination studies. If approved, label expansions for new cancer indications can boost sales.
In the past 60 days, estimates for Allogene Therapeutics’ 2024 earnings per share narrowed from $2.23 to $2.21. Year to date, shares of Allogene Therapeutics have lost 49.3%.
Earnings of Allogene Therapeutics beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 3.93%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 10.17%.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 41.5%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 60 days, estimates for Corcept Therapeutics’ 2023 earnings per share increased from 75 cents to 79 cents. During the same period, the earnings estimate per share for 2024 has improved from 81 cents to 83 cents. Year to date, shares of Corcept Therapeutics have risen 35.7%.
Earnings of Corcept Therapeutics beat estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing an average earnings surprise of 6.99%. In the last reported quarter, Corcept Therapeutics’ earnings beat estimates by 66.67%.
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CHMP Endorses Merck's (MRK) Keytruda Expansion in Gastric Cancer
Merck (MRK - Free Report) announced that the European Medicines Agency's (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) has given a positive opinion recommending label expansion to its blockbuster drug Keytruda as part of a combination regimen for a second indication in gastric cancer.
The CHMP has recommended approving Merck’s Keytruda, combined with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (“GEJ”) adenocarcinoma, whose tumors express PD-L1.
This recommendation is based on data from the phase III KEYNOTE-859 study, wherein patients treated with the Keytruda combination demonstrated a statistically significant improvement in overall survival compared to those patients who received chemotherapy only.
If approved, a combination therapy involving Keytruda will be available to patients with both HER2-negative and HER2-positive advanced gastric or GEJ adenocarcinoma whose tumors express PD-L1.
In August, the European Commission (“EC”) approved the combination of Keytruda, trastuzumab and chemotherapy for the first-line treatment of locally advanced unresectable or metastatic HER2-positive gastric or GEJ adenocarcinoma in patients whose tumors express PD-L1. Merck received accelerated approval from the FDA in 2021 for the Keytruda-trastuzumab-chemotherapy combination in a similar indication.
Merck’s shares have lost 6.3% year to date against the industry’s 8.5% growth.
Image Source: Zacks Investment Research
Keytruda, an anti-PD-1 therapy, is Merck’s blockbuster oncology drug approved for several types of cancer, accounting alone for around 40% of MRK’s pharmaceutical sales. Keytruda is presently authorized to treat seven indications in earlier-stage cancers in the United States. Merck’s Keytruda continuously grows and expands into new indications and markets globally.
Keytruda, the key revenue generator for Merck, is already approved for treating many cancers globally. In the first half of 2023, Merck recorded $12.1 billion in sales from Keytruda, up 20% year over year. Drug sales are gaining from continued strong momentum in metastatic indications and rapid uptake across recent earlier-stage launches. Keytruda is consistently growing and expanding into new indications and markets globally.
Merck is evaluating Keytruda across many indications that are progressing well. Keytruda is being studied for more than 30 types of cancer indications in more than 1600 studies, including combination studies. If approved, label expansions for new cancer indications can boost sales.
Merck & Co., Inc. Price
Merck & Co., Inc. price | Merck & Co., Inc. Quote
Zacks Rank & Stocks to Consider
Merck currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks are Allogene Therapeutics (ALLO - Free Report) , Annovis Bio (ANVS - Free Report) and Corcept Therapeutics (CORT - Free Report) , each carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 60 days, estimates for Allogene Therapeutics’ 2024 earnings per share narrowed from $2.23 to $2.21. Year to date, shares of Allogene Therapeutics have lost 49.3%.
Earnings of Allogene Therapeutics beat estimates in three of the trailing four quarters while meeting the mark on one occasion, witnessing an average earnings surprise of 3.93%. In the last reported quarter, Allogene Therapeutics’ earnings beat estimates by 10.17%.
In the past 60 days, estimates for Annovis Bio’s 2023 loss per share have narrowed from $4.89 to $4.38. During the same period, the loss estimates per share for 2024 have improved from $3.18 to $2.77. Year to date, shares of Annovis have lost 41.5%.
Earnings of Annovis Bio beat estimates in three of the last four quarters while missing the mark on one occasion, witnessing an earnings surprise of 13.40% on average. In the last reported quarter, Annovis’ earnings beat estimates by 6.14%.
In the past 60 days, estimates for Corcept Therapeutics’ 2023 earnings per share increased from 75 cents to 79 cents. During the same period, the earnings estimate per share for 2024 has improved from 81 cents to 83 cents. Year to date, shares of Corcept Therapeutics have risen 35.7%.
Earnings of Corcept Therapeutics beat estimates in two of the trailing four quarters while missing the mark on the other two occasions, witnessing an average earnings surprise of 6.99%. In the last reported quarter, Corcept Therapeutics’ earnings beat estimates by 66.67%.